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NCT07293598Not yet recruiting

Investigation of the ROle of faT and inflAmmaTory Cells in mElanoma

A Clinical, Histological, Cellular and Molecular Investigation of the Role of Fat and Inflammatory Cells in Melanoma Plasticity and Metastases

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

This study is a retrospective, proof-of-concept sample study to investigate a novel histological finding within the primary melanoma tumour in a large population of melanoma patients to assess its prognostic significance. This is a aims to validate the striking observation that a cross-talk between fat cells and leukocytes at the primary melanoma site promotes metastasis. In our unpublished pilot study, we have discovered an interesting finding whereby inflammatory cells extend from the tumour to and invading fat in the subcutaneous tissue and/or around the appendageal structures in the dermal skin in metastatic melanomas with distinct architectural changes within the fat. This finding was consistently present in metastatic and absent in non-metastatic melanomas. This new finding has both clinical and pathophysiological credence. Archival tissue blocks or human cell lines will be used in the first instance. As mitigation, experiments will be repeated with conditioned media obtained from co-culture of mixed primary immune cells obtained from peripheral blood mononuclear cell (PBMCs) and adipocytes induced from stem cells. This study aims to: * Investigate if the crosstalk between fat cells and tumour-infiltrating inflammatory cells defines the aggressiveness of primary cutaneous melanomas. * Identify and perform biological spatial analysis of the inflammatory cells between the tumour and fat in the primary tumours. * Investigate the interactions of fat cells and/or inflammatory cells in mediating melanoma cellular plasticity. The patients have not provided consent and will be justified in this application

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
8 Dec 2025
Start date
Jan 2026
Primary completion date
Jan 2027
Lead sponsor
The Christie NHS Foundation Trust
NCT number
NCT07293598

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From Jan 2026 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Inadequate slide quality
  • Unable to view the entire cross section of the skin with the primary tumour hence, unable to assess the invasion of inflammatory cells into fat

Who the study is looking for

  • Melanomas treated between 1st January 2006 and 31st December 2015 OR
  • Patients treated at the Christie between 2014 and 2019.
  • Review of histological slides for presence or absence of relevant histological features.
    • For group 3 and group 4:
  • Unique features of spitzoid melanomas

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.